Phase 1 Single Dose Escalation Study of CTB-001

HLB Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: CTB-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01647893

CTB-001

Details and patient eligibility

About

A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects

Enrollment: 33 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult males aged 20 to 40 years at screening.
• Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion criteria

• History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
• History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
• History of known hypersensitivity to drugs including CTB-001

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 4 patient groups

CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose

Experimental group

Treatment:

Drug: CTB-001

CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose

Experimental group

Treatment:

Drug: CTB-001

CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose

Experimental group

Treatment:

Drug: CTB-001

CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation

Experimental group

Treatment:

Drug: CTB-001